Skip to main content
SpringerLink
Log in

To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm

  • Academic Exploration
  • Published:
Chinese Journal of Integrative Medicine Aims and scope Submit manuscript

Abstract

The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in mainland China recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for effificacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this fifield both in China and abroad are urgently needed.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. OCEBM Levels of Evidence Working Group. Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence. [2016-11-10]. Available at: http://www.cebm.net/wp-content/uploads/2014/06/CEBM-Levels-of-Evidence-2.1.pdf.

  2. Gordon HG, Andrew DO, Gunn EV, Regina K, Yngve FY, Pablo AC, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336: 924–926.

    Article  Google Scholar 

  3. Murad MH, Asi N, Alsawas M, Alahdabnew F. New evidence pyramid. Evid Based Med 2016;21: 125–127.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Milano G. The hierarchy of the evidence based medicine pyramid: classification beyond ranking. Joints 2015;3: 101.

    PubMed  Google Scholar 

  5. Liliane Z, Yoon KL, John PI, Su G, Pasqualina S, Douglas GA, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ 2016;352: 1–17.

    Google Scholar 

  6. Sun SG. Report on species of traditional Chinese medicine injections postmarket in China. Chin Hosp Pharm J (Chin) 2015;35: 369–374.

    Google Scholar 

  7. Liao X, Nicola R. Methodological approaches to developing and establishing the body of evidence on post-marketing Chinese medicine safety. Chin J Integr Med 2013;19: 494–497.

    Article  PubMed  Google Scholar 

  8. Zhang N, Lu AL, Wang G, Chen G, Dang Q, Pei YH. Chemical constituents of Ixeris sonchifolia (Bge.) Hance. J Shenyang Pharm Univ (Chin) 2007;24: 549–551.

    CAS  Google Scholar 

  9. Faraoni D, Schaefer ST. Randomized controlled trials vs. observational studies: why not just live together? BMC Anesthesiol 2016;16: 1–4.

    Article  Google Scholar 

  10. Cortinovis M, Perico N, Remuzzi G. Should we still believe in randomized controlled trials in nephrology? Nephronoly 2016:1–6

    Google Scholar 

  11. Feng YS, Gui LH, Xu SM, Li YF, Zhang HW, Zhao HW. Studies on the activity of fibrinolysin and toxicity of Ixeris sonchifolia Hance. J Shenyang Coll Pharm (Chin) 1981;13: 23–29.

    Google Scholar 

  12. Mashour GA, Shanks AM, Kheterpal S. Perioperative stroke and associated mortality after noncardiac, nonneurologic surgery. Anesthesiology 2011;114: 1289–1296.

    Article  PubMed  Google Scholar 

  13. van Poucke S, Thomeer M, Heath J, Vukicevic M. Are randomized controlled trials the (g)old standard? from clinical intelligence to prescriptive analytics. J Med Internet Res 2016;18: 4–14.

    Article  Google Scholar 

  14. World Health Organization. WHO-adverse reaction terminology (WHO-ART). [2016-11-10]. Available at: http://www.umc-products.com/graphics/3149.pdf.

  15. McClellan M. Drug safety reform at the FDA—pendulum swing or systematic improvement? N Engl J Med 2007;356: 1700–1702.

    Article  CAS  PubMed  Google Scholar 

  16. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006;29: 385–96.

    Article  PubMed  Google Scholar 

  17. The use of the WHO-UMC system for standardised case causality assessment. [2016-11-10]. Available at: http://www.who-umc.org/graphics/24734.pdf.

  18. Antje N, Harald D, Hans-Ulrich P, Thomas B, Wolfgang R, Reinhold S, et al. E-pharmacovigilance: development and implementation of a computable knowledge base to identify adverse drug reactions. Br J Clin Pharmacol 2013;76: 69–77.

    Article  Google Scholar 

  19. Gliklich RE, Dreyer NA, Leavy MB, eds. Registries for evaluating patient outcomes: a user’s guide. 3rd ed. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014:93

    Google Scholar 

  20. Brighton B, Bhandari M, Tornetta PR, Felson DT. Hierarchy of evidence: from case reports to randomized controlled trials. Clin Orthop Relat Res 2003;413: 19–24.

    Article  Google Scholar 

  21. Abu KN, Abdullah B, Manikam J. The current status of the case report: terminal or viable? Biomed Imag Interv J 2009;5: 1–4.

    Google Scholar 

  22. Lécutier MA. Phocomelia and internal defects due to thalidomide. BMJ 1962;2: 1447–1448.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Moss P. Whither the case report? J Infect 2008;57: 93–94.

  24. Rosselli D, Otero A. The case report is far from dead. Lancet 2002;359: 84.

    Article  PubMed  Google Scholar 

  25. Trisha G, Jeremy H, Neal M, for the Evidence Based Medicine Renaissance Group. Evidence based medicine: a movement in crisis? BMJ 2014;348:g3725.

  26. World Health Organization, Quality Assurance and Safety of Medicines Team. Safety of medicines. A guide to detecting and reporting adverse drug reactions: why health professionals need to take action. 2002. [2016-11-10]. Available at: http://apps.who.int/iris/bitstream/10665/67378/1/WHO_EDM_QSM_2002.2.pdf.

  27. GRADE Working Group, GRADE Handbook. [2016-11-10]. Available at: http://gdt.guidelinedevelopment.org/app/handbook/handbook.html.

  28. Liu JP. The composition of evidence of traditional medicine and recommendations for its evidence grading. Chin J Integr Med 2007;27: 1061–1065.

    Google Scholar 

  29. Liao X, Xie YM, Wang YY, Robinson Nicola. To explore evidence evaluation for harm: establishing the body of evidence for harm for postmarketing traditional Chinese medicine. China J Chin Mater Med (Chin) 2015;40: 4723–4727.

    Google Scholar 

  30. Naranjo C, Busto U, Sellers EM. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30: 239–245.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China

    Xing Liao, Yan-ming Xie, Nicola Robinson & Yong-yan Wang

Authors
  1. Xing Liao
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Yan-ming Xie
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Nicola Robinson
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Yong-yan Wang
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Yan-ming Xie.

Additional information

Supported by the Ninth-Science Foundation of Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences (No. Z0406), the Seventh Science Foundation of China Academy of Chinese Medical Sciences (No. ZZ070817), National Natural Science Foundation of China (General Program, No. 81202776) and China Postdoctoral Science Foundation project (No. 2014T70202)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Liao, X., Xie, Ym., Robinson, N. et al. To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm. Chin. J. Integr. Med. 23, 226–232 (2017). https://doi.org/10.1007/s11655-016-2534-x

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11655-016-2534-x

Keywords

Search

Navigation